JP2019514489A - Implants and methods for the treatment of pelvic disease - Google Patents

Abstract

The present invention relates to a surgical implant having adjustable size features and a method of treating pelvic disease using the implant. [Selected figure] Figure 2

Description

[Cross-reference to related applications]
This application is related to US Provisional Patent Application No. 62 / US Application Ser. No. 15 / 489,211, filed Apr. 17, 2017, entitled "Implant and Method for Treatment of Pelvic Diseases," filed on April 17, 2017, claiming priority to US Pat. , And to claim priority to it.

  This application also claims priority to US Provisional Patent Application No. 62 / 325,269, filed April 20, 2016, the disclosure of which is incorporated herein in its entirety by reference.

  The present invention relates to a surgical implant comprising an implant material and a reinforcement effective to adjust the mechanical properties of the implant material, the surgical implant comprising a pelvic disease (e.g. incontinence, prolapse, levitation). Are useful in any of a variety of different surgical procedures, such as for treating heart disease, hernias, and the like.

  Surgical implants are used in a wide variety of different surgical procedures. Some forms of the implant are comprised of a material that includes a substantially planar, flexible, textile-type implant material. These implants are used to treat soft tissue disorders such as heart tissue, hernias, in the treatment of pelvic disorders such as incontinence and prolapse and other medicines by means of implant material used to support soft tissue. Can be used to treat a medical condition.

  With regard to pelvic health, this is a medical area of increasing importance for men and women at least partly due to aging. Examples of common pelvic chronic diseases include incontinence (eg, urine or feces), pelvic tissue prolapse (eg, female vaginal or levitation prolapse), uterus or bladder prolapse, and levator avulsion Such as pelvic floor muscle disease. Specific vaginal prolapses include non-apical diseases such as cystoceles and rectoceles, and vaginal fornix prolapse (ie, apical prolapse). Pelvic disorders such as these may result from weakness or damage to the normal pelvic support system.

  One form of non-apical prolapse is the prolapse of tissue in the anterior vaginal wall, eg, a cystocele. Rectal aneurysms, in contrast, are a form of non-apical posterior vaginal prolapse, ie, the escape of posterior vaginal wall tissue. A small intestinal mass is a vaginal hernia in which a peritoneal sac that encloses a portion of the small intestine extends into the recto-vaginal cavity. The apical prolapse, also called vaginal fornix prolapse, is distension (i.e., U.S. Patent Application Publication Nos. 2002/0028980, 2010/0184805, 2014/0005471, 2015/0057491). And U.S. Pat. Nos. 8,109,867, 8,720,446 and 8,956,276).

  Sacral vaginal fixation is known and surgically removing the patient's uterus if there is a uterus (hysterectomy), followed by hanging the vaginal wall or apex from the sacrum using a synthetic mesh Accompanied by This procedure returns the vaginal apex to its anatomical position and holds the tissue in place by the implanted mesh. This procedure restores the vaginal length and axis without compromising its inner diameter and is therefore likely to have a favorable functional outcome.

  According to certain SCP procedures, the surgical implant is a mesh pre-formed in "Y" shape with two front leaves connected to a single back or distal leaf. In use, the two anterior "leaves" (or "arms" or "appendages") of the "Y" shaped implant are surgically secured to the patient's anterior and posterior vaginal walls. The third portion of the Y-shaped mesh (i.e., the sacral leaf or sacral tail) is anchored in the posterior direction at or near the sacrum, as at the patient's anterior longitudinal ligament. An example of a currently marketed Y-shaped surgical implant is to seamlessly weave two vaginal appendages to form a sacral tail (BARD Alyte implant, ASTRA Y mesh implant), or a vaginal appendage And either ensure that the sacral tail is firmly joined with the sacral leaf in a three way joint (Coloplast Restorelle implant, Boston Scientific Upsylon implant, Caldera Vertessa implant).

  Sacral vaginal fixation to treat non-apical prolapse, as is typically done using a commercially available preformed non-regulatory Y-type implant, comprises two vaginal portions (leaf, appendage) of the implant at the apex of the vagina Adjacent to the anterior and posterior vaginal walls at the beginning of the sew. After attaching the vaginal leaf to the vaginal tissue, the desired tension, ie the amount of tension needed to suspend the vaginal tissue from the sacrum, is identified and the sacral tail of the implant is surgically attached to or near the sacrum Be Determining the correct amount of tension to place on the implant through the sacral leaf is very important to the success of the procedure. Excessive tension can lead to complications similar to urinary incontinence. Under tension can cause relapse.

US Patent Application Publication No. 2002/0028980 US Patent Application Publication No. 2010/0184805 US Patent Application Publication No. 2014/0005471 US Patent Application Publication No. 2015/0057491 U.S. Patent No. 8,109,867 U.S. Pat. No. 8,720,446 U.S. Pat. No. 8,956,276 US Patent Publication No. 2012/0184805 U.S. Pat. No. 9,060,836 US Patent Publication No. 2014/0257032 US Patent Application No. 2013/0109910

  In the past, adjustable implants have also been described as being useful for treating apical vaginal prolapse. See, for example, U.S. Patent Publication No. 2012/0184805. However, previous implants have been used with methods of treating non-apical prolapse by a sequence of method steps as described herein, or for example non-apical anterior and posterior vaginal tissue using non-transvaginal methods It does not seem to have been used to place differential tension and support.

  In accordance with the present invention, an adjustable Y-type surgical implant useful for treating vaginal prolapse, for example, apical prolapse, non-apical vaginal prolapse, or both, when the implant is surgically placed on the posterior and vaginal tissues Can be used to provide improved positioning of the anterior and posterior vaginal leaves of the implant and therapeutic effects by providing differential tension and support at the

  Y-shaped pre-formed and non-adjustable surgical implants useful for SCP procedures include fixed total length, fixed size (including length) of two vaginal leaves extending from sacral leaf, fixed size of sacral leaf (including length) And. Implants of this type, which are not adjustable with respect to their size characteristics, are typically arranged in a manner to evenly distribute the tension placed on the sacral tail between the anterior and posterior vaginal appendages (leafs) of the mesh Ru. See FIG. 2 where T1 is approximately equal to T2. This type of even distribution of tension and support between the two vaginal leaves is desirable and useful primarily for patients with vaginal fornix (i.e., apical) prolapse.

  In patients with various levels of cystocele and / or rectum, optionally with apical prolapse, ie non-apical prolapse, surgical treatment of the disease is compared to the tension placed on the posterior vaginal wall Different amounts of tension can be improved by placing them on the anterior vaginal wall. For example, if the patient has significant anterior wall prolapse as compared to the posterior wall, the anterior vaginal wall is considered to benefit from the additional amount of support as compared to the posterior wall. This is the front appendage of the Y-shaped implant attached to the anterior vaginal tissue (ie, the anterior attachment (ie, the anterior portion of the anterior vaginal tissue) as compared to the amount of tension placed on the posterior appendage attached to the posterior vaginal tissue It will need to be placed on the vaginal leaf). In such cases, when determining the sacrococcygeal tension based on an appropriate amount of anterior wall support and using a standard Y-shaped implant, it can result in excessive tension on the posterior side leading to complications There will be (see Figure 2). This is because the way a surgeon typically applies tension to a preformed Y mesh is solely due to the amount of tension placed on the sacral tail.

  In accordance with the present invention, the physician differentially tensions the anterior and posterior appendages of the Y-type (Y-shaped) implant during surgical placement of the implant so that the surgeon responds to a wide range of prolapsed conditions that he copes with on a constant basis. You can wish. Non-adjustable Y-type implants do not provide the surgeon with the ability to place different levels of tension on the posterior vs. anterior vaginal tissue by adjusting the implant, and usually the tension in the sacral tail (sacral leaf) is two vaginas It is arranged in an evenly distributed manner between the appendages (between the anterior and posterior vaginal leaves).

  As one way to circumvent the limitations of preformed non-adjustable Y-type implants, the physician can now use two separate mesh implant parts, one for the anterior vaginal wall and a second for the posterior wall. The parts of and can now be used, both parts being attached separately to the sacrum. See FIG. With the two mesh portions, the surgeon can separately control the amount of tension acting on each one and achieve the desired result of differential tension on the anterior and posterior vaginal tissue. The disadvantage of this solution is that it is necessary to surgically attach (e.g., sew) two separate mesh sections separately to the sacrum. Attaching the two ends of the two mesh sections separately to the sacrum is one of the most dangerous stages of the procedure given the proximity of the attachment points to the main blood vessels and ureter. Thus, the probability of causing significant harm to the patient doubles when double stitching, due to the need to attach the two mesh sections separately. This solution also increases the total procedure time as the attachment to the sacrum is typically time consuming and needs to be done twice.

  The present invention describes a new method for treating vaginal prolapse where an adjustable implant is used to selectively distribute tension placed on the anterior portion of the vaginal tissue and independently of it. Do. Depending on the particular escape disease of the patient, the support given to the posterior vaginal tissue can be applied at different levels compared to the support given to the anterior vaginal tissue. For example, the amount of anterior tension relative to posterior tension is based on the specific type and combination of prolapsed tissue present in the patient's vaginal tissue, especially compared to the degree of prolapse found in the patient's non-apical posterior tissue. It can be selected based on the presence and relative degree of prolapse found in the apical vaginal tissue. In certain ways, the vaginal leaf of the adjustable implant can be attached to the anterior and posterior vaginal tissue, eg, the non-apical tissue of the anterior and posterior vaginal walls. After the vaginal leaf is fixed to the vaginal tissue, the length of one or more of the one or two vaginal leaves can be adjusted. Adjusting the length or lengths of the vaginal leaf can produce differential tension and differential support applied to different vaginal tissues supported by each of the two vaginal leaves. Thereafter, the amount of tension desired to be present in the sacral leaf can be determined, and the sacral leaf can be attached to the tissue in the area of the sacral anatomical structure.

  The implants useful herein can be any Y-type implant that includes adjustability features that allow for differential support of non-apical anterior vaginal tissue to non-apical posterior vaginal tissue. Non-limiting examples of useful implants are described herein, including those described as having a movable connector attached to a fixed length base.

  As used herein, the term "distal" in relation to the patient's anatomy or device, part of the device, or method described herein refers to the direction towards the back of the patient, eg, the vagina or The term "proximal" in reference to the patient's anatomy or device or method described herein, which points in a direction towards the sacrum with respect to the uterus, refers to the direction towards the front of the patient, eg, in relation to the sacrum Point towards the vaginal tissue or urethra.

  As used herein, the term "securely attached" refers to separation of the two structures during normal use and operation of the device as described including, for example, surgical placement of the leaf and movement of the moveable connector. Refers to the attachment between two structures in a non-intrusive manner, eg between the implant material of the leaf or base of the implant and the connector of the implant, the two structures being substantially in a manner that is believed to damage the device It can only be separated by the application of a substantial force which is believed to cause at least one of the tear, tear or cut. As an example, the two structures can be attached in such a way as to cause them to remain attached for the purpose of surgical placement and implant use. The "securely attached" structure may be by adhesive, by thermoplastic bonding (eg molding), by ultrasonic bonding, by permanent or positive frictional engagement such as a clasp or a jagged surface, or by implant The two structures can be held together by any useful fixation mechanism or technique, such as by another attachment mechanism designed and possible to hold the two structures together during or after surgical placement.

  The term "movably attached" as in the movable connector movably attached to the base along the width of the base means that the connector moves along the length of the base and maintains engagement with the base Refers to the engagement between these two structures that allows. The moveable connector is attached to the base and contacts the base in a manner that allows the slider to move (eg, slide) to a different location along the length of the base while maintaining contact with the base.

FIG. 1 shows an example of a conventional implant and method. FIG. 1 shows an example of a conventional implant and method. FIG. 1 shows an example of the implant and method of the present invention. FIG. 1 shows an example of the implant and method of the present invention. It is a figure which shows the example of the implant of this invention. It is a figure which shows the example of the implant of this invention. It is a figure which shows the example of the implant of this invention. It is a figure which shows the example of the implant of this invention. It is a figure which shows the example of the implant of this invention. It is a figure which shows the example of the implant of this invention. FIG. 6 shows an example of connector features of the implant according to the invention. FIG. 6 shows an example of connector features of the implant according to the invention. FIG. 6 shows an example of connector features of the implant according to the invention. FIG. 6 shows an example of connector features of the implant according to the invention. FIG. 6 shows an example of connector features of the implant according to the invention. FIG. 6 shows an example of connector features of the implant according to the invention. FIG. 6 shows an example of a adjustable implant in a manner as described. FIG. 6 shows an example of a adjustable implant in a manner as described.

  All drawings are schematic and not to scale.

  Described herein are, for example, prolapse of non-apical anterior and posterior vaginal tissue such as cystoceles or rectoceles, or prolapse of apical vaginal tissue that means vaginal fornix prolapse, or a combination thereof. Surgical implants and related methods useful for treating vaginal prolapse in female patients. The patient's uterus will have been removed by previous or concurrent surgical procedures.

  An implant useful for performing any of the described methods generally includes a distal portion positioned during use in the area of the sacrum and a proximal portion positioned during use in the area of vaginal tissue . The distal portion comprises a sacral leaf (or "appendix"). The proximal portion includes an anterior vaginal leaf (or "appendix") and a posterior vaginal leaf (or "appendix"). In use, the anterior vaginal leaf can be surgically secured in contact with anterior vaginal tissue, resulting in effective support for anterior vaginal tissue in the surgical treatment of non-apical anterior vaginal prolapse It is possible. The posterior vaginal leaf can be surgically sewn in contact with posterior vaginal tissue, so that it can be effective to support posterior vaginal tissue as part of the surgical treatment of non-apical posterior vaginal prolapse is there. Alternatively or additionally, the combined anterior and posterior vaginal leaves can be placed on the tissue of the vaginal apex or vaginal cuff to support the vaginal apex to treat the apical prolapse . In these treatments, the sacral leaf is suspended by attaching it to a posterior location, such as tissue in the anatomical region of the sacrum, thereby supporting the proximal portion of the implant attached to the vaginal tissue.

  Embodiments of implants useful in the described methods are adjustable to allow differential placement of tension and support relative to anterior vaginal tissue as compared to posterior vaginal tissue. An exemplary implant includes a movable joint located at a three-way intersection (i.e., a junction) of the anterior vaginal leaf, the posterior vaginal leaf, and the sacral leaf. The movable non-stationary joint is where the distal end of the anterior vaginal leaf meets the distal end of the posterior vaginal leaf, where the distal end of the anterior vaginal leaf and the distal end of the posterior vaginal leaf Each meets the proximal end of the sacral leaf. According to the present specification, the joint is movable along at least a portion of the implant length and movable with respect to the length of the sacral sac leaf and also movable with respect to at least one of the two vaginal leaves. Can. Due to the mobility of the joint, the sacral leaf length between the proximal sacral leaf end (co-location with the location of the joint) and the distal sacral leaf end is adjustable, ie the implant The movement of the junction along the length can selectively increase or decrease. Furthermore, due to the joint being movable, at least one of the two vaginal leaves between the proximal vaginal leaf end and the respective distal vaginal leaf end (co-located with the joint location) The length is adjustable, ie, can be selectively increased or decreased by movement of the junction along the length of the implant. According to certain such embodiments of the implant, the length of one of the two vaginal leaves is adjustable by movement of the movable joint and the length of the second vaginal leaf is fixed when the joint is moved Be done. According to another embodiment, the lengths of both of the two vaginal leaves are independently adjustable, for example by the movement of the movable joint relative to each leaf.

  Adjustable implants, such as the implants described herein, including movable joints, for example, sacral bone with desirable or improved therapeutic results for treating non-apical anterior vaginal prolapse, non-apical posterior vaginal prolapse It may be particularly useful in performing vaginal fixation. The implant can be adjustable to allow surgical placement in a manner that allows the surgeon to achieve differential tension and support of anterior vaginal tissue as compared to posterior vaginal tissue. For example, an adjustable implant having a moveable joint is selective to different supporting tissues, allowing the surgeon to position the joint or adjust the length of the appendage (leaf) relative to the implant. Support and improve the therapeutic effect and treatment of the implant.

  Certain useful adjustable implants include a movable joint that allows the surgeon to move the location of the two vaginal leaves and the trifurcation of the sacral leaf, and the surgeon may use one or both of the two vaginal leaves. It is possible to adjust the length and, if necessary, to provide a geometric asymmetry with respect to the length of the two vaginal leaves. By allowing the movement of the joint during the surgical placement of the implant and the optional asymmetry of the vaginal leaf length, it is possible to apply differential tension to the anterior and posterior vaginal walls. For example, the mobile joint can be adjusted to increase the relative level of support placed on the anterior vaginal tissue to treat a patient with anterior vaginal tissue prolapse. Alternatively, the mobile joint can be adjusted to increase the relative level of support placed on the posterior vaginal tissue to treat patients with posterior vaginal tissue prolapse.

  FIG. 3 shows an example of a Y-shaped implant as described, where the mobile joint provides a relatively more support for the anterior vaginal tissue 102 as compared to the posterior vaginal tissue 104. Positioned along the length. For example, as described herein (see below), after the anterior vaginal leaf 14 and the posterior vaginal leaf 16 have been secured to the anterior vaginal tissue 102 and the posterior vaginal tissue 104, eg, by sutures 30, respectively. The movable connector 24 is adjusted as part of the implant 2, preferably held in place or locked. Following attachment of the vaginal leaf to the respective vaginal tissue, adjustment of the movable connector 24 and locking of the movable connector 24 into place along the length of the implant 2, the sacral leaf 20 is adjusted and then the sacrum 112 Attached to the anatomical region of the sacrum, such as The geometric asymmetry (e.g., different lengths) of the anterior vaginal leaf 14 and the posterior vaginal leaf 16 is due to the lack of tension (T) present in the sacral leaf 10 between the anterior vaginal leaf 14 and the posterior vaginal leaf 16. Cause uniform distribution.

  As shown in FIG. 4, the total sacral tension T is distributed more to the anterior appendage as compared to the posterior appendage, ie, the tension T 1 of the anterior vaginal leaf 14 is greater than the tension T 2 of the posterior vaginal leaf 16. As shown in FIG. 4, with reference to the alternative embodiment, the sacral tension T is distributed more to the posterior appendage as compared to the anterior appendage, ie, the tension T2 of the posterior vaginal leaf 16 is the anterior vaginal leaf 14 Tension T1 of According to certain embodiments, the adjustable Y-shaped implant has a fixed length of continuous implant material between the distal base end at the distal end of the implant and the proximal base end at the proximal end of the implant Can include a base. A sacral leaf extends distally from the junction to the distal base end for attachment to tissue in the anatomical region of the sacrum. For example, a first vaginal leaf, such as an anterior vaginal leaf, extends proximally from the junction to the proximal base end to support vaginal tissue, such as anterior vaginal tissue. A second vaginal leaf extends proximally from the junction to the proximal base end for attachment to vaginal tissue, such as posterior vaginal tissue. Each leaf has a width independently. The joint is a movable joint movable along the length of the base between the distal base end and the proximal base end. The first vaginal leaf extends between the proximal base end and the movable joint. A sacral leaf extends between the mobile joint and the distal base end. A second vaginal leaf, also made of implant material, extends from the movable joint.

  According to these embodiments, each of the two vaginal leaves may be of a single density (material weight) and in the form of a single layer of implant material. The sacral leaf can also be of a single layer and can exhibit the same single density of material weight as the vaginal leaf. Alternatively, the sacral reef can be manufactured in two layers (ie, two layers of implant material) and may be double density (twice material weight) compared to the vaginal leaf, ie, The total weight of the sacral leaf material can be twice the weight of a single density vaginal leaf.

  The various support portions (base and vaginal and sacral leaf) of the implant are surgically placed on the tissue in contact with the tissue in the patient's pelvic area and in a manner to support the tissue as treatment for vaginal prolapse Composed of surgical implant material intended to be fixed.

  The surgical implant material can be a substantially planar, flexible porous implant material adapted to be surgically disposed to support vaginal tissue. Many examples of flexible implant materials including porous (e.g. mesh) materials prepared by assembling strands of fibers such as polymer monofilaments into flexible planar woven, nonwoven or knitted fabric are It is known and commercially available. Alternative implant materials can be molded, extruded, cut or otherwise formed to include pores in the form of open fields, openings, or fenestrations adapted to allow tissue ingrowth after implantation .

  Suitable implant materials are known, examples of which are commercially available for use as surgical implant materials for supporting anatomical tissue. These are woven, knitted, extruded or otherwise produced open pore (porous) materials woven from connected strands, fibers, yarns, filaments (eg monofilaments), treated films etc. Inclusion, they can be natural or synthetic. Exemplary implant materials are woven with interconnected, tied or otherwise connected filaments or fibers forming many fiber junctions and many regular or random sized and spaced openings. And includes non-woven (but still fibrous or filamentous), knitted or other materials. Implant materials made from monofilament or multifilament fibers are useful for treating vaginal prolapse and two or more types of different fibers (monofilaments, multifilaments, etc.) assembled together to prepare the implant material The same applies to materials containing or combinations thereof. Fiber joints can be formed by other joint forming techniques, including weaving, bonding (eg, adhesive bonding, thermal bonding, etc.), bundling, ultrasonic welding, knitting, or combinations thereof. The resulting openings, pores, openings, or fenestrations, etc., size may allow for tissue ingrowth and establishment of open pore implant material in the contacted tissue after the implant has been placed in an anatomical location such as vaginal tissue. And enough to make it possible. By way of example and not limitation, the openings of the open pore implant material may have diagonal dimensions or diameters ranging from about 0.040 inches (1.016 mm) to about 0.055 inches (1.397 mm) It can take the form of an oval, square, circular, rectangular or diamond shaped opening with dimensions.

  The strands, layers, filaments, etc. of the open pore implant material can be of any material useful for forming a surgical implant. Suitable natural materials and polymeric materials are biocompatible, optionally bioresorbable, and can be coated to facilitate tissue ingrowth or prevent infection. Examples include nylon, polyolefins such as polyethylene terephthalate, polypropylene and polyethylene, poly-L-lactide (PLLA), polyethylene glycol (PGA), polyester, and any combination of materials. Depending on the desired treatment, the polymer can be absorbable, nonabsorbable or resorbable. Examples of commercially available implant materials include those sold under the trade names Prolene®, Deldene®, and Marlex® implantable materials. Yet another example is a woven polypropylene monofilament knitted with warp tricot.

  Other examples of implant materials are preformed materials, such as single or homogeneous patterned implants as described in US Pat. Nos. 9,060,836 and 2014/0257032 Each of these documents, including the materials, is incorporated herein by reference in its entirety. Examples of single or homogeneous patterned implants as described in these documents can be comprised of patterned cells formed by molding, die casting, laser etching, laser cutting, extrusion, and the like. Each portion of the implant material (e.g., as formed in the anterior portion) may be sinusoidal or otherwise in a manner that allows for desirable control of extension, expansion, contraction along the axis or axes of the anterior portion. Can be formed into corrugated post members. The distribution of stress, tension, and compression can be controlled over specific or localized areas of the implant material or anterior portion. In certain embodiments, the shaped implant material can provide desirable one-dimensional or two-dimensional stretch characteristics to a portion of the described implant, such as, for example, the anterior portion. For example, the pre-moulded portion can have an extension characteristic such that the front portion stretches in two dimensions (i.e. becomes longer) if pressure is applied in only a single direction relative to the front portion, e.g. The front portion can be elongated along different axes when a force is applied along a single axis.

  Referring now to FIGS. 5A (side view) and 5B (top view), the implant 2 is between the distal base end 6 at the distal end of the implant and the proximal base end 8 at the proximal end of the implant. It is a Y-shaped implant comprising a base 4 with a fixed length of implant material. The sacral leaf 10 extends distally from the mobile joint 12 to the distal base end 6. A first vaginal leaf 14, eg, an anterior vaginal leaf, extends proximally from the junction 12 to the proximal base end 8. A second vaginal leaf 16, eg, a posterior vaginal leaf, extends proximally from the junction 12. Each leaf 10, 14 and 16 has an independent width.

  The joint 12 is a movable joint movable along the length of the base 4 between the distal base end 6 and the proximal base end 8. The first vaginal leaf 14 extends between the proximal base end 8 and the movable joint 12 and the length of the vaginal leaf 14 is due to the movement of the connector 12 between the proximal base end 8 and the distal base end 6 It can be increased or decreased (see arrows in FIGS. 5A and 5B). A sacral leaf 10 extends between the mobile joint 12 and the distal base end 6.

  The implant 2 of FIGS. 5A and 5B securely attaches the distal end 20 of the second vaginal leaf 16 to the joint 12. The length of the second vaginal leaf 16, ie the distance between the distal end 20 (at its secure attachment to the connector 12) and the proximal (free) end 22 is fixed. This fixed length of the second vaginal leaf 16 does not change with the movement of the joint 12 along the length of the base 4.

  The junction 12, which means the intersection of the leaves 10, 14 and 16, can move along the length of the base 4. For example, by a mechanical connector 24 in the form of a clasp or slider that can be freely moved along the length of the base 4 while maintaining engagement with the base 4 and all three leaves 10, 14 and 16 , Can be moved. As shown in FIGS. SA and SB, the connector 24 extends around the implant material (e.g. mesh) that continuously extends from the distal end of the connector 24 to the proximal end while making up the base 4. An inner opening 34 (shown in dashed lines) may be included to accommodate and allow sliding movement of the connector 24 across the width of the base 4 and along its length.

  6A (side view) and 6B (top view) show an alternative embodiment of the implant 2. Shown is a base having a fixed length of implant material (eg, a continuous implant material) between the distal base end 6 at the distal end of the implant and the proximal base end 8 at the proximal end of the implant 4 is a Y-shaped implant. The sacral leaf 10 extends distally from the mobile joint 12 to the distal base end 6. A first vaginal leaf 14, eg, an anterior vaginal leaf, extends proximally from the junction 12 to the proximal base end 8. A second vaginal leaf 16, eg, a posterior vaginal leaf, extends proximally from the junction 12. Each leaf 10, 14 and 16 has an independent width. The distal part of the base 4 between the junction 12 and the distal base end 6 (this part of the base 4 is also the sacral leaf 10) is made of two layers of implant material, ie vaginal leaves 14 and 16 Double density (twice material weight) compared to. The two layers are optionally attached to the distal portion of the sacral leaf 10, such as by sutures 28 (other attachment means would be useful).

  With further reference to FIGS. 6A and 6B, junction 12 is a movable junction movable along the length of base 4 between distal base end 6 and proximal base end 8. The first vaginal leaf 14 extends between the proximal base end 8 and the movable joint 12 and the length of the vaginal leaf 14 is of the movable joint 12 between the proximal base end 8 and the distal base end 6. It can be increased or decreased by movement (see arrow). A sacral leaf 10 extends between the mobile joint 12 and the distal base end 6. Joint 12 meaning the intersection of leaves 10, 14 and 16 is free, for example, along the length of base 4 while maintaining engagement with base 4 and all three leaves 10, 14 and 16 It is movable using a mechanical connector 24 in the form of a clasp or slider that can be moved to As shown in FIGS. 6A and 6B, the connector 24 fits around and accommodates the implant material (e.g., mesh) that comprises the base 4, and the connector 24 extends across the width of the base 4 and along its length. Can include an inner opening (shown in dashed lines) that allows for sliding movement of the With the implant 2 of FIGS. 6A and 6B, the location of the distal end 20 of the second vaginal leaf 16 is controlled by the location of the connector 24. The length of the second vaginal leaf 16, ie the distance between the distal end 20 (at its secure attachment to the connector 12) and the proximal (free) end 22 is consequently based on the movement of the connector 24 Is adjustable.

  Although not shown in FIGS. 5A, 5B, 6A, and 6B, preferred features of the connector 24 selectively apply friction between the connector 24 and the base 4 to frictionally engage the connector 24 with the implant material of the base 4 Locking engagement, or alternatively, selectively apply and remove friction between connector 24 and base 4 to frictionally engage or disengage connector 24 with the implant material of base 4 Frictional engagement (eg, selectively engageable or selective locking).

  As shown in FIGS. 7A and 7B, implant 2 includes a connector 24 having a frictional engagement that can selectively apply and remove friction between connector 24 and base 4. The button 25 is selectively pushed or released to move up and down relative to the base 4 (see arrow) and frictionally engage the frictional engagement of the connector 24 (not shown) with the implant material of the base 4 It can be released or released. The button 25 is biased to raise (do not push down) when no pressure is applied, which causes the frictional engagement of the connector 24 to engage the base 4, and the connector 24 along the length of the base 4. Control movement and substantially block it. In use, the surgeon can apply pressure to the button 25, which releases the frictional engagement of the connector 24 from the base 4 and allows free movement of the connector 24 relative to the base 4. Once the surgeon has identified the desired location of the connector 24 along the length of the base 4, the button 25 is released and the frictional engagement of the connector 24 re-engages the base 4 and again the connector along the length of the base 4 Control the movement of 24 and substantially block it.

  Referring to FIGS. 8A and 8B, shown is an example of an implant 2 that includes a connector 24. The connector 24 includes a frictional engagement that can be selectively engaged or subsequently released with the base 4 to respectively inhibit or allow movement of the connector 24 along the length of the base 4. The connector 24 includes a housing 32, a frictional engagement 30 (teeth, elongated extension, bump, point, repeat (eg, jagged surface, etc.), a spring 27, and the distal end 40 of the housing 32 from the distal end 40 of the housing 32. And an opening 34 extending to the end 42.

  As shown in FIG. 8A, the button 25 of the connector 24 is depressed to press the spring 27 to bias the button to extend (see FIG. 8B). In FIG. 8A, the frictional engagement 30 is also in a position not in frictional engagement with the implant material of the base 4 that is also internal to the connector 24 and extends into the opening 34 between the distal end 40 and the proximal end 42 ) And the button 25). In this configuration, with the button 25 depressed, the connector 24 can be moved freely along the length of the base 4 to increase or decrease the length of one or more leaves of the implant 2. The illustrated frictional engagement 30 penetrates the implant material of the base 4 and, for example, the through-bore of the implant material (e.g. the pores of the implantable mesh material or larger openings formed in the implantable mesh material) Extend through. Alternatively, the opposing surface 31 (which may be flat or include its own friction features) with sufficient force to inhibit or prevent movement of the connector 24 along the length of the base 4 The friction engagement 30 may simply apply pressure to the implant material, such as by pressing the implant material against (which can).

  With further reference to FIGS. 8A and 8B, the button 25 is selectively pushed or released to move up and down relative to the base 4 (see arrows) and the frictional engagement 30 inside the connector 24 with the implant material of the base 4. It can be frictionally engaged or disengaged. The button 25 is biased by the spring 27 to lift up while no pressure is applied, ie, the frictional engagement of the connector 24 with the base 4 thereby restraining movement of the connector 24 along the length of the base 4 And is biased to substantially block. In use, the surgeon can apply pressure to the button 25 and depress the button 25 to release the frictional engagement 30 of the connector 24 from the base 4 allowing free movement of the connector 24 relative to the base 4. See Figure 8A. Once the surgeon has identified the desired location of the connector 24 along the length of the base 4, the button 25 is released and the frictional engagement 30 of the connector 24 re-engages the base 4 again along the length of the base 4. The movement of the connector 24 is suppressed and substantially blocked. See Figure 8B.

  Referring to FIGS. 9A and 9B, shown is another alternative to implant 2 and connector 24 at junction 12. The connector 24 includes the connector features of FIGS. 8A and 8B, and additionally includes a block 46 that can be selectively engaged (FIG. 9A) and released (FIG. 9B) with the button 25. When the block 46 engages the button 25, the button 25 is depressed and the frictional engagement 30 is released from the implant material of the base 4. In this configuration, the connector 24 can move relative to the base 4. Once the surgeon has identified the desired location of the connector 24 along the length of the base 4, the button 25 can be released by removing the block 46 from the button 25, as shown in FIG. 4 to restrain and substantially block movement of the connector 24 along the length of the base 4.

  Referring now to FIGS. 10A and 10B, shown is an example of an implant 2 that includes an alternative connector 24 at junction 12. FIG. The connector 24 includes a housing 32, a movable frictional engagement 60, an opening 34 extending from the distal end 40 of the housing 32 to the proximal end 42 of the housing 32, and an opening 66 in the housing 32 adapted to receive the shaft 62. And other features similar to the connector 24 of FIGS. 8A, 8B, 9A, and 9B.

  The connector 24 of FIGS. 10A and 10B may be inserted into and through a friction (eg, locking) engagement 60 or an opening 66 including (optional) extensions or teeth 64 including pegs or shafts 62 extending therefrom. Other friction mechanisms are included that allow movement of the shaft 62 to inhibit or prevent reverse movement of the engagement 60. The frictional engagement 60 may be initially released to allow movement of the connector 24 distally and proximally along the length of the base 4. In this configuration, with the frictional engagement 60 released, the connector 24 is free to move along the length of the base 4 to increase or decrease the length of one or more leaves of the implant 2 it can. Once the surgeon has identified the desired location of the connector 24 along the length of the base 4, the frictional engagement 60 may be directed into or through the implant material of the base 4 and then through the opening in the housing 32. 66 can be pushed through. Referring to FIG. 10B, the frictional engagement 60 engaged with the base 4 and the housing 32 is shown in a manner that constrains and substantially prevents movement of the connector 24 along the length of the base 4. The size of the shaft 62 is typically to engage openings in the implant material of the base 4 such as pores or other openings or openings in the implant material due to its manufacture by knitting or weaving It can be assumed. Alternatively, the implant material of the base 4 can have an expanded, cut or perforated opening through which the shaft 62 passes and an optional reinforcement (e.g. an eyelet). This expanded, cut or perforated opening is selected by the surgeon and then locks the connector 24 in place by movement of the frictional engagement 60 through the opening 66 of the housing 32 through the implant material It can be located at a position on the base that makes it possible.

  Referring now to FIGS. 11 and 12 (side view), certain relevant features of the female anatomical structure are shown in the uterus-extracted patient. The anatomical structures shown are the vagina (V) 100, anterior vaginal tissue 102, posterior vaginal tissue 104, bladder (B) 108, rectum (R) 110, and sacrum (S) 112 (i.e., sacral horn angle and anterior sacrum. An anatomical region of the sacrum, including ligaments and the like, none of which is specifically shown), and a vaginal fornix (i.e., a vaginal apex) 120.

  The method of placing the implant as described can be performed by surgical techniques involving one or more stages of conventional known sacral vaginal fixation. This procedure may be useful for treating non-apical vaginal prolapse, apical prolapse, or a combination of non-apical vaginal prolapse and apical vaginal prolapse. A useful procedure involves surgically implanting an area of non-apical vaginal tissue (eg, anterior vaginal tissue or posterior vaginal tissue), vaginal cuff, or a combination thereof (eg, sacral anatomy (eg, bone itself)) It needs to be suspended (using an implant such as a strip of mesh) against the nearby sacrospinous ligament, uterine sacral ligament, fascia of or near the sacrum, or anterior longitudinal ligament of the sacral horn.

  The surgical implant comprises placing the differential tension or support on the anterior vaginal tissue as compared to the support disposed on the posterior vaginal tissue to treat non-apical prolapse as described herein. It can be any surgical implant that will be determined to be useful for implementation. While examples of adjustable implants are described and illustrated herein, methods of using adjustable implants as described herein for applying differential tension to anterior tissue as compared to posterior tissue include: None is limited and not required for certain implant designs, for example, it does not require the use of the adjustable implant described herein. Other adjustable Y-type surgical implants are known and may be useful in the methods described herein. See, for example, U.S. Patent Application Nos. 2012/0184805 and 2013/0109910. The disclosures of which are incorporated herein by reference in their entirety. In addition to the implants specifically described herein, the implants of these patents, or their modified features or modifications or deformations, differentially tension the non-apical anterior vaginal tissue as compared to the non-apical posterior vaginal tissue. Or it can be appreciated that it is useful to practice the methods as described herein, including applying a support.

  According to an exemplary method, an adjustable Y-shaped implant (eg, as described) secures a first vaginal leaf to anterior vaginal tissue, secures a second vaginal leaf to posterior vaginal tissue, and a sacral leaf Can be surgically positioned in a tissue in the anatomical region of the sacrum. After placement of the two vaginal leaves and fixation of both leaves to the vaginal tissue, the user (e.g., a surgeon) can adjust the location of the movable connector along the length of the base. Movement of the connector along the base can be used to adjust the length of one or the other of the vaginal leaf (see, eg, FIGS. 3, 4 and 11), or to adjust both lengths of the vaginal leaf simultaneously. It can be considered effective (see FIG. 12). When using an implant as shown in FIGS. 5A and 5B, an adjustable length vaginal leaf may be surgically secured to vaginal tissue on one side of the vagina (eg, non-apical anterior vaginal tissue) The second vaginal leaf of fixed length (with respect to the joint 12) can be surgically fixed on the second side of the vagina (for example, non-apical posterior vaginal tissue; see FIGS. 3 and 11) . Alternatively, with the fixed length vaginal leaf surgically fixed to the anterior vaginal tissue, the adjustable length vaginal leaf can be surgically fixed to the posterior vaginal tissue (see FIG. 4) .

  An exemplary step of the surgical method includes cutting out two vaginal leaves as needed to fit the anterior and posterior vaginal tissue. The surgeon then desires to apply separately to each of the anterior and posterior vaginal tissue the desired level of support and tension, depending on the degree and type of disease, such as, for example, cystoceles, rectoceles, or both. Can be determined. The relative amount of support and tension can be achieved by movement of the moveable connector adjusting the length of one or more of the vaginal leaves, with the desired location of the moveable connector determined, eg, moveable connector By activating the frictional or locking engagement of the connector, the connector can be locked in place. During or after these stages, the surgeon can determine the desired amount of sacral tension to be placed on the sacral leaf, which may be tissue, for example, in the anatomical area of the patient's sacrum, such as the sacral horn angle Can be attached to

  Useful methods can be performed by abdominal incision, vaginal incision, laparoscopic or optionally using robotic surgical equipment. Examples of known methods which are different from those of the present specification but which may have one or more method steps in common are described in US Patent Application Publication Nos. 2002/0028980, 2010/0184805. , 2014/0005471, 2015/0057491, 2013/0109910, and U.S. Patent Nos. 8,109,867, 8,720,446, and No. 8,956,276, the entire contents of which are incorporated herein by reference. Referring to FIG. 11, for example, as shown in FIGS. 5A and 5B, an adjustable Y-shaped implant including an anterior vaginal leaf 14, a posterior vaginal leaf 16, a sacral leaf 10, and an adjustment mechanism (e.g., movable connector 24). It is shown. The implant 2 attaches the anterior vaginal leaf 14 to the anterior vaginal tissue 102 and the posterior vaginal leaf to the posterior vaginal tissue 102 when surgically placed on a patient without uterus to support non-apical vaginal tissue. Attached and positioned with the sacral leaf 10 attached to the tissue at the anatomical area of the sacrum, it supports the implant 2 and vaginal tissue fixed to the vaginal leaf. During implantation, the sliding joints may be placed at different locations on the base (4) mesh by the physician. The location of the sliding joint along the length of the base (4) is that the tension (T) applied to the sacral leaf is between the anterior vaginal leaf (with tension T1) and the posterior vaginal leaf (with tension T2) Will decide how to be distributed. Referring to FIG. 11, T = T1 + T2 is shown.

  FIG. 12 is similar in many respects but differs in that it shows the implant 2 described in FIGS. 6A and 6B.

FIG. 12 is similar in many respects but differs in that it shows the implant 2 described in FIGS. 6A and 6B.
The present invention may have the following aspects.
(1) A method of treating vaginal fornix prolapse in a female patient, comprising providing a Y-shaped implant comprising an anterior vaginal leaf, a posterior vaginal leaf and a sacral leaf, the three leaves comprising A junction connected at least one of the anterior vaginal leaf and the posterior vaginal leaf is an adjustable length vaginal leaf, the vaginal leaf being between the junction and the proximal end of the vaginal leaf The steps of preparing, adjusting the length, attaching the anterior vaginal leaf to the patient's anterior vaginal tissue, attaching the posterior vaginal leaf to the patient's posterior vaginal tissue, the posterior vagina In order to increase or decrease the amount of tension applied by the implant to the anterior vaginal tissue relative to the amount of tension applied by the implant to tissue, in front of the at least one adjustable length vaginal leaf Method characterized by comprising the steps of adjusting the length, the.
(2) After attaching the anterior vaginal leaf to the anterior vaginal tissue and after attaching the posterior vaginal leaf to the posterior vaginal tissue, relative to the amount of tension applied by the implant to the posterior vaginal tissue Adjusting the length of the at least one adjustable length vaginal leaf to increase or decrease the amount of tension applied by the implant to the anterior vaginal tissue.
(3) After adjusting the length, attaching the sacral leaf to tissue in the area of the patient's sacral anatomical structure.
(4) The method includes the step of treating a cystocele, wherein said adjusting includes said amount of tension greater than said amount of tension placed on said posterior vaginal tissue said non-apical anterior vaginal tissue Including placing on top.
(5) The method includes the step of treating a rectocele, wherein the adjusting step comprises an amount of tension greater than the amount of tension placed on the posterior vaginal tissue on the non-apical posterior vaginal tissue Including the steps of
(6) adjusting the length of the implant material between the joint and a first position of attachment of the anterior vaginal leaf to the anterior vaginal tissue is the joint and the posterior vagina Adjusting the length of the at least one adjustable length vaginal leaf to be less than a length of implant material between the first position of attachment of the posterior vaginal leaf to tissue.
(7) adjusting the length of the implant material between the joint and a first position of attachment of the anterior vaginal leaf to the anterior vaginal tissue is the joint and the posterior vagina Adjusting the length of the at least one adjustable length vaginal leaf to be greater than the length of implant material between the first position of attachment of the posterior vaginal leaf to tissue.
(8) The method comprises the step of treating a rectocele, enterocele, or a combination thereof, wherein said adjusting comprises an amount of tension greater than the amount of said tension disposed on said anterior vaginal tissue. Placing on the posterior vaginal tissue.
(9) The implant comprises a base including a length and a width of an open pore implant material between a first end with the sacral leaf and a second end with the first vaginal leaf A second vaginal leaf including a loose end, a proximal end, a length between the loose end and the proximal end, and a width, the second vaginal leaf being The base is met to form a movable joint, which allows movement of the position of the joint along the length of the base.
(10) adjusting the implant to apply unequal tension to the anterior and posterior vaginal tissue.

Claims (21)

A Y-shaped surgical implant,
A base comprising a fixed length of implant material between the distal base end and the proximal base end, a sacral leaf, a first vaginal leaf and a width;
A movable joint movable along the length between the distal base end and the proximal base end;
Including
The first vaginal leaf extends between the proximal base end and the movable joint,
The sacral leaf extends between the movable joint and the distal base end,
A second vaginal leaf comprising implant material extends from the moveable joint
An implant characterized by   The movable joint is mounted to the base along a width of the base to allow the movable joint to maintain engagement with the base while being moved along the length of the base. The implant according to claim 1, characterized in that it is movably mounted.   The second vaginal leaf has a second vaginal leaf length between the second vaginal leaf distal end and the loose proximal vaginal leaf end at the mobile joint, the second vaginal leaf The implant according to claim 1 or 2, wherein the leaf length is fixed.   The implant according to claim 3, wherein the distal end of the second vaginal leaf is securely attached to the movable joint.   The second vaginal leaf has a second vaginal leaf length between the distal second vaginal leaf end and the loose proximal vaginal leaf end at the mobile joint, the second vaginal leaf The implant according to claim 1, wherein the length is adjustable by the movement of the movable joint along the length of the base.   The first vaginal leaf has a length between the first base end and the position of the movable joint along the length of the base, and the length of the first vaginal leaf The implant according to claim 1, characterized in that it is adjustable by the movement of the mobile joint along the length of the base.   The sacral leaf has a length between the second base end and the position of the mobile joint along the length of the base, the length of the sacral leaf being the length of the base 7. An implant according to claim 1 or 6, which is adjustable by the movement of the slider along its length.   The movable joint includes a slider that is securely attached to the distal end of the second vaginal leaf, the slider moving with the base as the slider moves along the length of the base. The implant according to claim 1, characterized in that it is movably attached to the base along the width of the base so as to make it possible to maintain the engagement. The moveable joint includes a frictional engagement that can be selectively placed in an open or closed configuration,
With the frictional engagement in the open configuration, the moveable connector can be moved along the length of the base while maintaining engagement with the base, the frictional engagement being in the open configuration. In the closed configuration, the frictional engagement frictionally impedes movement of the movable connector along the length of the base.
The implant according to any one of claims 1 to 6, characterized in that:   10. An implant according to claim 9, wherein the locking engagement is selected from an open biased spring loaded frictional engagement and a closed biased spring loaded frictional engagement.   Allows the first vaginal leaf and the second vaginal leaf to be secured to non-apical anterior and posterior vaginal tissue while the sacral leaf extends to the area of the sacrum and is secured thereto in tissue An implant according to any of the preceding claims, characterized in that it is A method of treating vaginal fornix prolapse in a female patient, comprising:
Providing a Y-shaped implant comprising an anterior vaginal leaf, a posterior vaginal leaf and a sacral leaf, the three leaves being connected at a junction, the anterior vaginal leaf and the posterior vaginal leaf Providing at least one of the adjustable length vaginal leaf, the length of the vaginal leaf between the junction and the proximal end of the vaginal leaf being adjustable;
Attaching the anterior vaginal leaf to anterior vaginal tissue of a patient;
Attaching the posterior vaginal leaf to the posterior vaginal tissue of the patient;
The at least one adjustable length vaginal leaf to increase or decrease the amount of tension applied by the implant to the anterior vaginal tissue relative to the amount of tension applied by the implant to the posterior vaginal tissue Adjusting the length of the
A method characterized by comprising.   After attaching the anterior vaginal leaf to the anterior vaginal tissue and after attaching the posterior vaginal leaf to the posterior vaginal tissue, the anterior relative to the amount of tension applied by the implant to the posterior vaginal tissue 13. Adjusting the length of the at least one adjustable length vaginal leaf to increase or decrease the amount of tension applied by the implant to the vaginal tissue. The method described in.   14. A method according to claim 12 or claim 13 comprising attaching the sacral leaf to tissue in the area of the patient's sacral anatomical structure after adjusting the length. The method comprises the steps of treating a cystocele
The adjusting step includes disposing an amount of tension on the non-apical anterior vaginal tissue that is greater than the amount of tension disposed on the posterior vaginal tissue.
The method according to any one of claims 12 to 14, characterized in that. The method comprises the steps of treating a rectocele.
The adjusting step includes disposing an amount of tension on the non-apical posterior vaginal tissue that is greater than the amount of tension disposed on the posterior vaginal tissue.
The method according to any one of claims 12 to 14, characterized in that.   The adjusting step comprises: a length of implant material between the joint and a first position of attachment of the anterior vaginal leaf to the anterior vaginal tissue is the length of the implant material to the joint and the posterior vaginal tissue. Adjusting the length of the at least one adjustable length vaginal leaf to be less than a length of implant material between the first position of attachment of the posterior vaginal leaf The method according to any one of claims 12-16.   The adjusting step comprises: a length of implant material between the joint and a first position of attachment of the anterior vaginal leaf to the anterior vaginal tissue is the length of the implant material to the joint and the posterior vaginal tissue. Adjusting the length of the at least one adjustable length vaginal leaf so as to be greater than the length of implant material between the first position of attachment of the posterior vaginal leaf The method according to any one of claims 12-16. The method comprises the steps of treating a rectocele, a fistula, or a combination thereof,
The adjusting step includes disposing an amount of tension on the posterior vaginal tissue that is greater than the amount of tension disposed on the anterior vaginal tissue.
19. A method according to any one of claims 12 to 18, characterized in that. The implant is
A base comprising a length and a width of an open pore implant material between a first end with the sacral leaf and a second end with the first vaginal leaf;
The second vaginal leaf including a loose end, a proximal end, a length between the loose end and the proximal end, and a width;
Including
The second vaginal leaf meets the base to form a movable joint, which allows movement of the position of the joint along the length of the base.
19. A method according to any one of claims 12 to 18, characterized in that.   13. The method of claim 12, comprising adjusting the implant to apply unequal tension to the anterior and posterior vaginal tissue.

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